TRANSCYTE (DERMAGRAFT-TC)
FDA premarket approval P960007/S009 · decided 1998-12-01
Approval details
- PMA number
- P960007
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRANSCYTE (DERMAGRAFT-TC)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1998-07-24
- Decision date
- 1998-12-01
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics. The product release criteria of the ATP assay stipulate that production lots of TransCyte will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.
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